Sat.Feb 11, 2023 - Fri.Feb 17, 2023

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How epilepsy researchers are moving the needle past anti-seizure treatments

Pharmaceutical Technology

While several therapeutics are available for treating symptoms associated with epilepsy, researchers and patients have strongly called out the need for more holistic treatments that would address the condition as a whole. Although recently approved drugs can treat seizures more safely, they do not treat the comorbidities that patients experience. Several biotech companies and researchers are now exploring medical devices and gene therapies to address not just common forms of epilepsy, but also r

Research 264
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US agrees to buy more doses of Novavax’s COVID shot

Bio Pharma Dive

The company said its modified contract with the federal government, which comes ahead of a planned transition to private market sales, will help it develop an updated version of its vaccine.

Sales 342
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Researchers find nanoparticles of a rare earth metal used in MRI contrast agents can infiltrate kidney tissue

Medical Xpress

Physicians routinely prescribe an infusion containing gadolinium to enhance MRI scans, but there is evidence that nanoparticles of the toxic rare earth metal infiltrate kidney cells, sometimes triggering severe side effects, University of New Mexico researchers have found.

Research 145
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Current treatments for cramps aren’t cutting it. Why aren’t there better options?

STAT News

One day last fall, Kiran’s period cramps became so painful they woke her up from a nap. The 19-year-old took some ibuprofen, but found little relief. “The pain was so bad, it felt like someone was punching me,” said Kiran, who asked to be referred to by only her first name for privacy. It felt “like I was giving birth.

Research 145
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Leading innovators in kidney disorder treatment compositions for the pharmaceutical industry

Pharmaceutical Technology

The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Kidney disorder treatm

Antibody 263
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Apellis wins FDA approval of first drug for type of vision loss

Bio Pharma Dive

Apellis’ Syfovre is the first marketed treatment for geographic atrophy, a common and irreversible eye condition. But questions linger about its benefit and safety.

More Trending

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Spain approves menstrual leave, teen abortion and trans laws

NPR Health - Shots

Among the enacted changes, 16- and 17-year-olds will be allowed to undergo an abortion without parental consent. And workers suffering debilitating period pain can take paid time off.

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Innovation in immuno-oncology: Leading companies in cancer monoclonal antibody therapy

Pharmaceutical Technology

The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms and the gravity of unmet need, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Immuno-oncology: Leading companies in cancer monoclonal

Antibody 261
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A new generation of biotech leaders is emerging. Can they change how drug startups are built?

Bio Pharma Dive

Through social media, virtual meetings and mentorship programs, a growing group of entrepreneurs is looking for new ways to build drug companies.

Drugs 363
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STAT+: In about-face, Moderna vows Americans won’t have to pay for its Covid-19 vaccine

STAT News

In an unexpected shift, Moderna has decided not to ask Americans to pay for its Covid-19 vaccine, a move that follows intense criticism over initial plans to charge $110 to $130 per dose after the company pivots from government contracts to commercial distribution. The vaccine maker released a brief statement that it “remains committed” to ensuring everyone in the U.S. has access to its Covid-19 shot, regardless of whether they have health insurance coverage.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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A new, experimental approach to male birth control immobilizes sperm

NPR Health - Shots

For decades researchers have struggled to find a contraceptive methods for males. A new fast-acting compound shows promise — assuming it turns out to work as well in men as in mice.

Research 145
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Innovation in biosimilars: Leading companies in neuro-degenerative receptor binding drug compositions

Pharmaceutical Technology

The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Biosimilars in Pharmaceuticals: Neuro-degenerative re

Drugs 246
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New cancer cell therapy biotech emerges, backed by MD Anderson and Replay

Bio Pharma Dive

Syena will develop TCR-based natural killer cell therapies, building on research done by MD Anderson’s Katy Revzani and using technology from Replay.

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Opinion: The haunting brain science of long Covid

STAT News

Matt Fitzgerald used to bike up and down 3,500 feet through the Santa Ana Mountains on three-hour rides just for fun. Now, nine months after being infected with SARS-CoV-2, the virus that causes Covid-19, he can’t muster walking on flat surfaces for 20 minutes without days of exhaustion. “My long Covid life remains terrifying,” he told me.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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ERs staffed by private equity firms aim to cut costs by hiring fewer doctors

NPR Health - Shots

Increasingly, private equity firms shape staffing decisions at hospital emergency rooms, research shows. One apparent effect: Hiring fewer doctors and more health care practitioners who earn far less.

Doctors 145
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Innovation in immuno-oncology: Leading companies in gene therapy delivery using viral vectors

Pharmaceutical Technology

The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Immuno-oncology in Pharmaceuticals: Gene therapy deli

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With Aera, CRISPR pioneer Feng Zhang goes after gene therapy’s delivery problem

Bio Pharma Dive

The company’s platform technology is built on research from Zhang’s lab at the Broad Institute, which focuses on a proteins that could be used to package and deliver nucleic acids.

Packaging 316
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STAT+: CRISPR pioneer Feng Zhang launches new genetic delivery startup with $193 million

STAT News

Akin Akinc was scouring his email spam box last summer, looking for a missing message, when he stumbled across an unexpected email from a quite recognizable name: Feng Zhang. Zhang, one of the leading scientists in the groundbreaking field of genetic editing, had reached out two days prior to discuss a new company he was working on. Since helping to discover CRISPR-Cas9 — often referred to as molecular scissors that can cut into the genome and edit DNA — Zhang has founded at least

Genetics 142
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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Actor Bruce Willis has frontotemporal dementia. Here's what to know about the disease

NPR Health - Shots

Willis family announced Thursday that his previous diagnosis of aphasia has progressed to frontotemporal dementia. The disease can cause issues with speaking and writing.

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Leading innovators in kidney disorder treatment compositions for the pharmaceutical industry

Pharmaceutical Technology

The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Kidney disorder treatm

Antibody 242
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Pfizer, Valneva remove half of participants from study of Lyme disease shot

Bio Pharma Dive

Violations of study standards by a “third-party clinical trial site operator” prompted the partners to stop evaluating a large portion of the volunteers in their trial, the largest test of a Lyme disease vaccine in decades.

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Study suggests fructose could drive Alzheimer's disease

Medical Xpress

An ancient human foraging instinct, fueled by fructose production in the brain, may hold clues to the development and possible treatment of Alzheimer's disease (AD), according to researchers at the University of Colorado Anschutz Medical Campus.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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How do pandemics begin? There's a new theory — and a new strategy to thwart them

NPR Health - Shots

Animals carry millions of pathogens. So it's a daunting task to find the one with the greatest potential to spark a pandemic. Now scientists are rethinking the way they hunt for that next new virus.

Scientist 142
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MD Anderson and Xilis partner to expedite new cancer therapies development

Pharmaceutical Technology

The University of Texas MD Anderson Cancer Center has entered a strategic collaboration with biotech company Xilis for advancing new technology and expediting new cancer therapy development. The preclinical research deal will combine the MicroOrganoSphere (MOS) platform of Xilis with the expertise of MD Anderson for advancing new therapies development and cancer research.

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Talaris restructures, ending effort to develop a cell therapy for kidney transplants

Bio Pharma Dive

Following a patient death and difficulty enrolling study participants, the company is laying off a third of its staff and ending a pair of studies for a two-decade-old program once owned by Novartis.

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Transcendental meditation helps to alleviate burnout in academic physicians

Medical Xpress

Transcendental Meditation (TM) is a viable and effective intervention to decrease burnout and depression among academic physicians, according to a study published online Jan. 26 in the Journal of Continuing Education in the Health Professions.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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Opinion: The X-waiver for buprenorphine prescribing is gone. It’s time to spread the word

STAT News

Signing into law a change that can prevent thousands of Americans from dying of opioid overdoses should have been met with fanfare. Instead, it not only slid under the media radar but hasn’t been communicated to the people who need to know about it. Included in the end-of-year appropriations bill that President Biden signed on December 29, 2022 was the bipartisan Mainstreaming Addiction Treatment (MAT) Act of 2023.

Drugs 136
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10 things to know about how social media affects teens' brains

NPR Health - Shots

Eye-opening testimony from a top scientist offers a useful primer on the role social media may play in the teen mental health crisis. (Image credit: Tracy J.

Scientist 138
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Gilead’s Shaw to step down from role running cell therapy unit

Bio Pharma Dive

Shaw, who joined Gilead in 2019 from Eli Lilly, helped build Kite into a leading producer of cell therapies, convincing Wall Street skeptics in the process.

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Mixed results for Moderna mRNA flu vaccine trial

Medical Xpress

US biotech company Moderna said Thursday it had mixed results from a large-scale trial of its mRNA flu shot, based on the same technology used in its successful Covid-19 vaccine.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.